This article argues that supported decision making is ideal for people with dynamic cognitive and functional impairments that place them at the margins of autonomy. First, we argue that guardianship and similar surrogate decision-making frameworks may be inappropriate for people with dynamic impairments. Second, we provide a conceptual foundation for supported decision making for individuals with dynamic impairments, which integrates the social model of disability with relational accounts of autonomy. Third, we propose a three-step model that specifies the necessary conditions (...) of supported decision making: identifying domains for support; identifying kinds of supports; and reaching a mutually acceptable and formal agreement. Finally, we identify a series of challenges for supported decision making, provide preliminary responses, and highlight avenues for future bioethics research. (shrink)
Equipoise is an essential condition to justify a clinical trial. The term, describes a state of uncertainty: the data suggest but do not prove a drug's safety and efficacy The only way to resolve this uncertainty is further study In many cases, a clinical trial seems to be the most efficient way to prove safety and efficacy Equipoise is therefore not an esoteric philosophic construct applied to research ethics. Rather, since it is vital for the justification of clinical trials, it (...) is part of how society regulates medical progress. Where there is equipoise, drug design and development proceeds according to Food and Drug Administration and Health and Human Services regulations. When that equipoise ends, a drug is either not approved or becomes standard care. (shrink)
Previously diagnosed by symptoms alone, Alzheimer's disease is now also defined by measures of amyloid and tau, referred to as “biomarkers.” Biomarkers are detectible up to twenty years before symptoms present and open the door to predicting the risk of Alzheimer's disease. While these biomarkers provide information that can help individuals and families plan for long-term care services and supports, insurers could also use this information to discriminate against those who are more likely to need such services. In this article, (...) we evaluate whether state laws prohibit long-term care insurers from making discriminatory or unfair underwriting and coverage decisions based Alzheimer's disease biomarkers status. We report data demonstrating that current state laws do not provide meaningful protections from discrimination by long-term care insurers based on biomarker information. (shrink)
Equipoise is an essential condition to justify a clinical trial. The term, describes a state of uncertainty: the data suggest but do not prove a drug's safety and efficacy The only way to resolve this uncertainty is further study In many cases, a clinical trial seems to be the most efficient way to prove safety and efficacy Equipoise is therefore not an esoteric philosophic construct applied to research ethics. Rather, since it is vital for the justification of clinical trials, it (...) is part of how society regulates medical progress. Where there is equipoise, drug design and development proceeds according to Food and Drug Administration and Health and Human Services regulations. When that equipoise ends, a drug is either not approved or becomes standard care. (shrink)
Supported decision making is a model of decision making in which an adult with impaired capacity enters freely into an agreement with a closely trusted person or persons (the “s...
Truth telling to persons living with dementia is a nuanced problem that demands negotiating between the hazards of principlism and the loving deceiver’s demand to lie as needed. To ban deception, as we do restraints, would be misguided and cruel. So too to demand we always tell the truth. We ought to adopt a practice called “creative care.” It begins with the premise that person’s living with dementia are capable of creativity. Creative care breaks down the mysterious fourth wall we (...) build around persons living with dementia, especially persons with advanced dementia. It invites us to see a person living with dementia as a person who is capable of creating something beautiful. They need our time and words, not our lies and sedatives. (shrink)
Years after the publication of “Helpful Lessons and Cautionary Tales: How Should COVID-19 Drug Development and Access Inform Approaches to Non-Pandemic Disease?” I hope it continues to animate and...
The preeminence of informed consent in human subjects protections reflects Western democratic societies' ethical and political commitments to secure each citizen against both coercive and paternalistic influences of other people. Society permits adults extensive personal discretion in choices such as where to live, what to eat, how to dress, and whether to be in research. In short, individuals are afforded extensive discretion in choosing what to do and what is in their own best interests. Informed consent to enroll in research (...) is especially important because research necessarily involves procedures such as randomization and blinding that are done to assure that the project will produce generalizable knowledge. (shrink)
